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Guidance on Preparation of a Product Registration …
MEDICAL DEVICE Guidance Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN common Submission Dossier template 21 October 2010 Guidance to common Submission Dossier template ACCSQ MEDICAL DEVICE Product WORKING GROUP Page 2 of 31 DRAFT PREFACE This document is intended to provide general Guidance . Although we have tried to ensure that the information contained here is accurate, we do not, however, warrant its accuracy or completeness.
An executive summary shall be provided with the common submission dossier template, which shall include the following information:- an overview, e.g., introductory descriptive information on the medical device, the intended uses and indications for use of the medical device,
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